VERSAWAVE DENTAL ER:YAG LASER SYSTEM

VERSAWAVE DENTAL ER:YAG LASER SYSTEM is an FDA 510(k)-cleared medical device (K041710) manufactured by Hoya Conbio. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 2, 2004. Regulation: 8.